September 4, 2020 - Roche (Basel, Switzerland) announced that the cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas 6800/8800 Systems received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). This test is intended for the simultaneous qualitative detection and differentiation of SARS-CoV-2, Influenza A, and Influenza B in … [Read more...]
Roche to launch SARS-CoV-2 Rapid Antigen Test in countries accepting CE Mark
September 2, 2020 - Roche (Basel, Switzerland) announced it will launch a SARS-CoV-2 Rapid Antigen Test in late September for markets accepting the CE Mark. Roche also intends to file for Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA). The SARS-CoV-2 Rapid Antigen Test is for use in point-of-care (POC) settings for both … [Read more...]
Thermo Fisher opens new site for manufacturing COVID-19 sample collection products
August 28, 2020 - Thermo Fisher Scientific Inc. (Boston, MA) announced that it has officially cut the ribbon on its new $40 million facility in Lenexa, Kansas, dedicated to viral transport media (VTM) production. The company also announced that the site will continue to expand to meet expected sustained demand for COVID-19 testing. Thermo Fisher says the facility has … [Read more...]
Quidel provides business update, isn’t concerned by Abbott’s new SARS antigen test
August 28, 2020 - Quidel Corporation (San Diego, CA) yesterday announced business updates and reaffirmed that it is “an industry leader in the introduction of FDA-authorized rapid tests for a wide range of diseases and medical conditions, [and] remains in the forefront of the battle against the COVID-19 pandemic.” Competition Was Expected “Abbott’s entry into the SARS … [Read more...]
CMS Updates Reporting, Testing Requirements for Labs, Healthcare Providers
August 26, 2020 - The Centers for Medicare & Medicaid Services (CMS) announced sweeping regulatory changes that require labs and other healthcare providers to test staff and offer testing to residents for COVID-19. Labs and nursing homes using point-of-care (POC) testing devices will be required to report diagnostic test results as required by the CARES Act (Coronavirus … [Read more...]
Quidel to update packaging of POC Sofia SARS Antigen test for COVID-19 to include either nasal or nasopharyngeal swabs
August 20, 2020 - Quidel Corporation announecd that labeling for Quidel’s Emergency Use Authorization (EUA) for the Sofia SARS Antigen FIA has been amended to include either nasal or nasopharyngeal swabs. The new kit labeling, with the addition of a nasopharyngeal swab, allows Quidel to offer a second kit configuration to support the nasopharyngeal sample … [Read more...]
BD Veritor System for COVID-19 testing now available
From the upcoming September edition of Repertoire Magazine. August 20, 2020 - Designed to meet the evolving and critical needs of point-of-care (POC) testing, the BD Veritor Plus system enables you to streamline the testing experience. Be ready for flu season by testing with CLIA-waived Flu A+B, Group A Strep, and respiratory syncytial virus (RSV) assays along with the … [Read more...]
Quidel expands training program; Maryland allows POC testing for COVID-19
August 11, 2020 - Quidel Corporation (San Diego, CA) announced that the State of Maryland has allowed point-of-care testing for COVID-19. Under the new directive, Maryland residents who believe they should be tested can now contact their healthcare provider, who can order a “COVID-19 test for any individual who believes it necessary, regardless of symptoms.” Separately, as … [Read more...]
Thermo Fisher develops COVID-19 antibody assay for transplant community
August 10, 2020 - Thermo Fisher Scientific (Waltham, MA) has developed a new serological assay targeted towards transplant candidates and recipients that can detect antibodies directed against COVID-19 (SARS-CoV-2). The assay will be provided under the company's One Lambda brand. In collaboration with histocompatibility, infectious disease and nephrology laboratories at … [Read more...]
OraSure announces progress on new COVID-19 testing products
August 06, 2020 - OraSure (Bethlehem, PA) along with its quarterly financial results, announced what the company is doing to help the industry combat the COVID-19 pandemic. The company says it is well positioned to support multiple modes for COVID-19 testing, including PCR/molecular, antigen, and antibody testing. To support capacity building for the company’s existing … [Read more...]